Evaluating outcomes for mothers and infants after exposure to Rimegepant during pregnancy
Official title: A Prospective, Registry-based, Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant: The Migraine Observational Nurtec Pregnancy Registry (MONITOR)
Run by Pfizer · NCT05046613 · Data updated 2026-11-12
This study is trying to see how taking the migraine medication Rimegepant during pregnancy affects the health of mothers and their babies compared to those who didn't take it.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Years and up |
| Sex | Women only |
| Enrollment | 780 (estimated) |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (Wilmington, North Carolina) |
| Status | Recruiting |
| Started | September 23, 2021 |
| Main results expected | November 4, 2029 |
| Study ends | April 30, 2034 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT05046613 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include pregnant women with a diagnosis of migraine who have either been exposed to Rimegepant or have not taken it during pregnancy.
✕Probably not a fit
Patients who have been exposed to other CGRP antagonists or ditans during pregnancy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the maternal, fetal, and infant outcomes for pregnant women diagnosed with migraines who have been exposed to Rimegepant, a medication used for migraine treatment. It will compare outcomes between those who have taken Rimegepant during pregnancy or just before conception and those who have not been exposed to the drug. The study will follow participants and their infants for up to 12 months to gather comprehensive data on health outcomes. The research is sponsored by Pfizer and conducted in collaboration with PPD.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effects of Rimegepant on pregnant women and their infants.
How similar studies have gone: While there have been studies on migraine treatments during pregnancy, this specific observational approach to Rimegepant is relatively novel and untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women with migraine exposed to rimegepant: a diagnosis of migraine and at least 1 dose of rimegepant during pregnancy or just prior to pregnancy (up to 3 days prior to conception) * Pregnant women with migraine unexposed to rimegepant: a diagnosis of migraine and no exposure to Rimegepant before or during pregnancy Exclusion Criteria: • Women exposed to other calcitonin gene-related peptide (CGRP)antagonists (e.g., ubrogepant), CGRP monoclonal antibodies, or ditans (e.g., lasmiditan) at any time during pregnancy or just prior to pregnancy
Where it's running
-
Evidera, a PPD business unit
Wilmington, North Carolina, United States Recruiting
Study contacts
- Study coordinator: Pfizer Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.